Suppliers / Rolabo Outsourcing Sl

Rolabo Outsourcing Sl

Spain Updated 9 July 2026

Rolabo Outsourcing Sl is an API manufacturer based in Spain. It holds 7 active US drug master files across a filed portfolio of 6 molecules.

7
active US DMFs
0
valid CEPs
0
registered plants
0
filings across 0 regulators

What they file, and where

Molecule Regulators Docs
Atropine US FDA 2
Cannabidiol US FDA 1
Loratadine US FDA 1
Palonosetron US FDA 1
Sirolimus US FDA 1
Tetrabenazine US FDA 1

Also appears on these molecule pages

Atropine API Cannabidiol API Loratadine API Palonosetron API Sirolimus API Tetrabenazine API

Questions about Rolabo Outsourcing Sl

Does Rolabo Outsourcing Sl hold a US DMF or a CEP?
Rolabo Outsourcing Sl holds 7 active US drug master files. A drug master file is a submission to the FDA describing how an ingredient is made; a CEP is the EDQM's certificate that the substance meets its European Pharmacopoeia monograph. Both are filings rather than approvals.
What does Rolabo Outsourcing Sl make?
6 molecules are on record against Rolabo Outsourcing Sl, including Atropine, Cannabidiol, Loratadine and Palonosetron. Each links through to that molecule's full manufacturer list.

Answered from this company's own record. Where a register holds nothing, the question is not asked rather than answered with a zero. How we count our figures.

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Ranked by shared active ingredients where we have them, otherwise by country and comparable credentials.

Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability